Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Docetaxel in Treating Patients With Relapsed Prostate Cancer

This study has been terminated.
(Drug supplier stopped funding due to loss of study drug (docetaxel) patent.)
Sponsor:
Collaborator:
Information provided by:
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00482274
First received: June 4, 2007
Last updated: July 5, 2011
Last verified: July 2011

June 4, 2007
July 5, 2011
May 2007
July 2009   (final data collection date for primary outcome measure)
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml [ Time Frame: While receiving study treatment (approximately 6 months) ] [ Designated as safety issue: No ]
Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.
Complete response rate as measured by serum PSA
Complete list of historical versions of study NCT00482274 on ClinicalTrials.gov Archive Site
  • Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml) [ Time Frame: Average days to develop recurrence from treatment start date amount applicable participants ] [ Designated as safety issue: No ]
    Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.
  • Time to Metastatic Disease [ Time Frame: Measured at Time of documented metastases (no historical estimate is available) ] [ Designated as safety issue: No ]
    Due to the limited enrollment, this analysis was not completed.
  • Time to Androgen Independent State [ Time Frame: Measured at date of documented androgen independence (no estimate available) ] [ Designated as safety issue: No ]
    Due to the limited enrollment, this analysis was not completed.
  • Time to Death From Any Cause [ Time Frame: measured at date of death (no estimate available) ] [ Designated as safety issue: No ]
    Due to the limited enrollment, this analysis was not completed.
  • Time to PSA recurrence as seen by 2 measurements performed a week apart
  • Time to metastatic disease
  • Time to androgen independent state
  • Time to death from any cause
Not Provided
Not Provided
 
Docetaxel in Treating Patients With Relapsed Prostate Cancer
Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.

OBJECTIVES:

Primary

  • Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.

Secondary

  • Determine the time to PSA recurrence in patients receiving this treatment.
  • Determine the time to metastatic disease in patients receiving this treatment.
  • Determine the time to androgen independent state in patients receiving this treatment.
  • Determine the time to death from any cause in patients receiving this treatment.

OUTLINE: This is an open label study.

Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: docetaxel
Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
Other Name: Taxotere
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
July 2009
July 2009   (final data collection date for primary outcome measure)

Criteria for Patient eligibility

Inclusion criteria

  1. Histologically confirmed adenocarcinoma of the prostate.
  2. Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
  3. Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months.
  4. Serum testosterone < 50 ng/ml.
  5. No evidence of metastases on bone scan.
  6. No evidence of metastases on CT scan of the abdomen and pelvis.
  7. ECOG performance status < 2.
  8. Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥ 100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN.
  9. Signed informed consent.

Exclusion Criteria

  1. A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
  2. Life expectancy < 3 months.
  3. Grade 2 or higher peripheral neuropathy.
  4. Prior investigational agent within the past 28 days.
  5. Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy.
  6. More than 12 months since initiation of androgen-deprivation therapy.
  7. Prior docetaxel chemotherapy.
  8. Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00482274
CDR0000546975, P30CA069533, OHSU-2838, OHSU-SOL-06076-LM
Not Provided
Tomasz M. Beer, OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Tomasz M. Beer, MD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP